Chemotherapy is not recommended for patients with TP53 mutation or del(17p) due to its poor efficacy in this setting. However, a number of patients may benefit from systemic therapy.

Fludarabine, cyclophosphamide and rituximab (FCR) chemoimmunotherapy has established curative potential for the subset of patients with favourable biologic features (IGVH mutated status and absence of TP53 dysfunction), and can be considered in younger, fit patients with adequate renal function (age < 65 with creatinine clearance ≥ 70 mL/min).

In patients with significant comorbidities or impaired organ function, less intensive chemoimmunotherapy such as chlorambucil and obinutuzumab or bendamustine and rituximab is also available. These treatments can be life-prolonging but do not have curative potential.

An allogeneic bone marrow transplant can be curative in patients with CLL but is rarely indicated. However, potentially suitable patients should be identified, and discussions with a linked transplantation service should begin early in the patient’s disease course.

Timeframes for starting treatment

Rate of disease progression is usually gradual and treatment initiation is rarely urgent. Timing should be discussed to align with the patient’s preferences but not delayed to the point where impaired performance status, compromised organ function or recurrent severe infections occur.

Training and experience required of the appropriate specialists

Haematologists/medical oncologists must have training and experience of this standard:

• Fellow of the Royal Australian College of Physicians (or equivalent)
• adequate training and experience that enables institutional credentialing and agreed scope of practice within this area (ACSQHC 2015).

Cancer nurses should have accredited training in these areas:

• anti-cancer treatment administration
• specialised nursing care for patients undergoing cancer treatments, including side effects and symptom management
• the handling and disposal of cytotoxic waste (ACSQHC 2020).

Systemic therapy should be prepared by a pharmacist whose background includes this experience:

• adequate training in systemic therapy medication, including dosing calculations according to protocols, formulations and/or preparations, such as those provided by eviQ .

If no haematologist/medical oncologist is locally available (e.g. regional or remote areas), some components of less complex therapies may be delivered by a general practitioner, general physician or nurse with training and experience that enables credentialing and agreed scope of practice within this area. This should be in line with a detailed treatment plan or agreed protocol, and with communication as agreed with the primary managing specialist or as clinically required.

The training and experience of the appropriate specialist should be documented.

Health service characteristics

To provide safe and quality care for patients having systemic therapy, health services should have these features:

• a clearly defined path to emergency care and advice after hours
• access to diagnostic pathology including basic haematology and biochemistry, and imaging
• access to appropriate molecular pathology access (not required on site and can be through central specialist laboratory)
• access to cytotoxic drugs prepared in a pharmacy with appropriate facilities
• occupational health and safety guidelines regarding handling of cytotoxic drugs, including preparation, waste procedures and spill kits (eviQ 2019)
• guidelines and protocols to deliver treatment safely (including dealing with extravasation of drugs)
• coordination for combined therapy with radiation therapy, especially where facilities are not co-located.